AIHIV: Peripheral Arterial Insufficiency Associated With HIV/AIDS
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the risk factors associated with the occurrence of arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this disease. The estimated prevalence is 10%, similar to that reported in the general population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size of 206 individuals was calculated. Data collection was performed in a prospective cross shape.
During the interview, written informed consent for inclusion in the study, along with a standard query of vascular surgery in which the patient's history as well as cardiovascular risk factors. Also, a vascular physical examination including palpation of pulses in upper and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a standardized method.
In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the arm circumference.
If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI measurements were performed at rest and effort, plus pressure index finger-arm or plethysmography. Patients with altered rates were followed in vascular surgery care.
The data were recorded in a single database unique protected by password. The results were analyzed using the statistical program STATA v 9.0.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arterial insufficiency and HIV Of a cohort of 206 HIV patients will be randomly selected 206 for Ankle-brachial index to identify wich suffer symptomatic or asymptomatic arterial insufficiency |
Procedure: Ankle-Brachial index
The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.
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Outcome Measures
Primary Outcome Measures
- Arterial insufficiency [1 time]
Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2
Secondary Outcome Measures
- Gender [1 time]
Male or Female
- Age [1 time]
Number of years
- Diabetes mellitus [1 time]
Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.
- Hypercholesterolemia [1 time]
Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.
- Hypertriglyceridemia [1 time]
Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.
- Hypoalphalipoproteinemia [1 time]
Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.
- Hypertension (High blood pressure) [1 time]
Defined as diagnosis in previous notes or use of antihypertensives.
- Ischemic heart disease [1 time]
Defined as previous heart attack.
- Stroke [1 time]
Defined as previous diagnosis in the record.
- Smoking [1 time]
Smoking yes or no.
- Smoking index [1 time]
Smoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.
- Drug abuse [1 time]
Defined as use or history of use of drugs of abuse investigated during the interview
- AIDS [1 time]
Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses
- Diagnostic Time of HIV [1 time]
Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.
- Viral Load [1 time]
Defined as the last number of copies of certain virus in patient serum in the record.
- CD4 [1 time]
Defined as the final determination of number of CD4 in serum.
- HAART (Highly active anti-retroviral therapy) [1 time]
Defined as use of at least one drug with anti-retroviral activity.
- Time HAART [1 TIME]
Defined as a period in months
Other Outcome Measures
- HIV [1 time]
Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.
Exclusion Criteria:
- Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | MExico city | D.F., Mexico | Mexico | 14000 |
Sponsors and Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
- Principal Investigator: Carlos A. Hinojosa, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Principal Investigator: Ana Elsa Núñez Salgado, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study Chair: Laura Jael del C. Ortiz López, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study Chair: Jaime Omar Herrera Cáceres, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study Chair: Brenda E. Crabtree Ramirez, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study Chair: Juan Sierra Madero, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- InstitutoNCMNSZ-CIIBH693